BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIKORALL OVERHEAD LIFT

    MDR report key: 21503018 · Received March 3, 2025

    Report

    Report Number
    8030916-2025-00040
    Event Type
    Malfunction
    Date Received
    March 3, 2025
    Date of Event
    December 24, 2024
    Report Date
    March 3, 2025
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FSA
    UDI-DI
    00887761979772
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE UNIT WAS RETURNED TO THE MANUFACTURER FOR INVESTIGATION WHERE THE UNIT WAS DISASSEMBLED AND THE MOTOR SHAFT BREAKAGE WAS CONFIRMED. A FUNCTIONAL TEST OF THE SINGLE FAULT SAFETY (SFS) SAFETY DRUM WAS PERFORMED BY MANUALLY PULLING THE LIFT STRAP AND CHECK FOR THE SFS TO START ADDING RESISTANCE TO THE LIFT STRAP. THE RESULT FROM THE TEST WAS THAT THE SFS SAFETY DRUM WAS NOT RESPONDING AS RAPIDLY AS EXPECTED. AFTER THE FUNCTIONAL TEST WAS PERFORMED, THE SFS SAFETY DRUM WAS OPENED TO EXAMINE THE OIL LEVEL. THE OIL LEVEL WAS FOUND TO BE BELOW THE SPECIFICATIONS, WHICH EXPLAINS WHY THE SFS SAFETY DRUM WAS NOT RESPONDING AS RAPIDLY AS EXPECTED DURING THE FUNCTIONAL TEST. THE RETURNED UNIT SHOWED NO SIGNS OF LEAKAGE WHEN IT ARRIVED AT THE SITE. NO VISIBLE STAINS THAT COULD INDICATE EARLIER LEAKAGES. THE UNIT WAS REPLACED FOR THE CUSTOMER. THE LIKORALL OVERHEAD LIFT IS INTENDED FOR USE IN, HEALTH CARE, INTENSIVE CARE AND REHABILITATION. LIKORALL OVERHEAD LIFT IS DESIGNED FOR FIXED INSTALLATION AND FREE-STANDING LIFT SYSTEMS. ALL COMMON LIFTS AND TRANSFERS CAN BE PERFORMED USING LIKORALL OVERHEAD LIFT, FOR INSTANCE BETWEEN BED/WHEELCHAIR, TO/FROM FLOOR, TOILET VISITS, GAIT TRAINING, AND TOGETHER WITH STRETCHERS. LIKORALL R2R (ROOM TO ROOM) OVERHEAD LIFT ENABLES THE PATIENT TO BE MOVED BETWEEN TWO RAIL SYSTEMS IN SEPARATE ROOMS. LIKORALL OVERHEAD LIFT WITH THE ES DESIGNATION IS PREPARED FOR OPERATION WITH THE WIRELESS HANDCONTROL REMOTE (IR) AND IN ADDITION, A TRANSFER MOTOR CAN BE CONNECTED FOR MOTOR DRIVEN MOVEMENT ALONG THE RAIL. LIKORALL S, IRC OVERHEAD LIFT IS PREPARED FOR CONTINUOUS CHARGING THROUGH THE RAILSYSTEM. ALTHOUGH THERE WAS NO REPORTED INJURY ASSOCIATED WITH THIS INCIDENT, REPORTS OF A MOTOR SHAFT BREAKAGE WHERE THE SFS DID NOT FUNCTION AS INTENDED COULD LEAD TO SERIOUS INJURY OR DEATH. BAXTER IS REPORTING THIS MALFUNCTION.

    Description of Event or Problem · 0

    BAXTER RECEIVED A CUSTOMER COMPLAINT REPORTING THE LIKORALL 242 ES R2R, HAD A SHAFT BREAKAGE WHERE THE USER HAS FALLEN BACK DOWN INTO THEIR STANDING SUPPORT. THIS OCCURRED DURING PATIENT USE. THERE WAS NO PATIENT/USER INJURY, MEDICAL INTERVENTION, SYMPTOM, OR ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    634517 LIKORALL OVERHEAD LIFT LIFT PATIENT NON AC POWERED FSA BAXTER HEALTHCARE CORPORATION 3122008 NA 00887761979772

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown